Kornimate/medical-research-clean huggingface dataset:
combination of metronomic capecitabine with camrelizumab for treatment of refractory solid tumor trial (cohort 3)

Conditions: Hepatobiliary, Pancreatic and Other Gastrointestinal Carcinoma (Non-stomach, Non-esophagi)

Summary: this is a single center phase 1 trial to observe safety and efficacy of metronomic capecitabine plus pd-l1 antibody camrelizumab to treat hepatobiliary, pancreatic and other gastrointestinal carcinoma (non-stomach, non-esophagi) patients who had disease progression after all standard regimens. this study is one of the cohorts of a multi-cohort trial called combination of metronomic capecitabine with camrelizumab for treatment of refractory solid tumor (mccrest) trial.

hepatobiliary, pancreatic and other gastrointestinal carcinoma (non-stomach, non-esophagi) patients who had disease progression after all standard regimens will be treated by metronomic capecitabine plus camrelizumab. metronomic capecitabine will be given as fixed dose (500mg bid) orally. camrelizumab will be given two-weekly (200mg once) intravenously. this regimen will be administered until progression of disease, intolerable toxicity or withdraw of consent.

Eligibility criteria:
inclusion criteria: 1. male/female patients aged≥18 years. 2. histologically confirmed hepatobiliary, pancreatic and other gastrointestinal carcinoma (non-stomach, non-esophagi), without uncontrolled pleural effusion or ascites. 3. patients with advanced or metastatic disease who have disease progression after all standard regimens, with measurable or unmeasurable lesions. 4. mss or pmmr. 5. ecog performance status 0 or 2, expected lifetime≥3 months. 6. adequate organ function: absolute neutrophil count (anc) ≥1.5x109/l, white blood count ≥3.5x109/l, platelets ≥75x109/l, hemoglobin (hb) ≥70g/l, alt/ast ≤2.5x uln (for patient with liver metastasis alt/ast ≤5x uln), serum bilirubin ≤1.5x uln, serum creatinine ≤1.5x uln. 7. hbv infected patients (inactive/asymptomatic carrier, chronic or active) with hbv dna\<500iu/ml (or 2500 copies/ml). 8. pregnancy test of female patients with fertile activity should be negative within 7 days before enrollment. patients should keep contraception during treatment. 9. willingness and ability to comply with the protocol for the duration of the study including scheduled visits, examinations, investigations and treatment plans with informed consent form. exclusion criteria: 1. pregnancy or children bearing potential. 2. brain or meningeal metastasis. 3. with second primary malignant diseases. 4. with uncontrolled auto-immune diseases, interstitial pneumonia, ulcerative colitis, or patients who should receive long-term glucocorticoid treatment (\>10mg/d prednisone). 5. with uncontrollable complications 6. inadequate organ function 7. conditions which impact on pill taking (dysphagia, chronic diarrhea, bowel obstruction). 8. known hypersensitivity reaction to any of the study drugs or components. 9. other unsuitable conditions determined by investigators.
virtual reality for pain and anxiety distraction strategy on office hysteroscopy

Conditions: Pain, Acute; Anxiety

Summary: hysteroscopy is a minimally invasive endoscopic technique that allows direct visualization of the uterine cavity and constitutes the gold standard for the diagnosis and treatment of most intrauterine pathology, such as heavy menstrual bleeding, fibroids, endometrial polyps, uterine malformations, etc. the "see and treat" strategy allows diagnosis and treatment in the same surgical act, and gives the technique a high resolution capacity, reducing the number of procedures the patient must undergo. the technological development of instruments has made it possible to have small-caliber endoscopic systems that have made this technique possible in an outpatient setting. outpatient management allows patients to avoid the possible risks and inconveniences associated with the surgical environment, such as the waiting list and the need for anesthesia, as well as an earlier return to their activities of daily life. despite the high resolution rates, a not inconsiderable percentage of women experience anxiety or pain during outpatient hysteroscopy, and this is the leading cause of treatment failure. in order to improve the tolerance and comfort of the patient, the usefulness of various strategies, both pharmacological and non-pharmacological, has been evaluated for pain reduction, with different results. virtual reality (vr) has been used successfully to reduce perceived pain in various procedures such as chronic pain, burns, dental processes, chronic pruritus or venipuncture. there is no published study to our knowledge that evaluates the usefulness of vr in reducing the levels of anxiety and pain perceived during a hysteroscopic procedure. the working hypothesis to be evaluated with this study is that the use of a vr device with reproduction of relaxing and distraction environments reduces the perception of pain and anxiety of the patient during an outpatient hysteroscopy.


Eligibility criteria:
inclusion criteria: * being over 18 years * understand and accept the study procedures * sign the informed consent. * indication of outpatient hysteroscopy according to the care protocols of the center * not taking drugs for the treatment of anxiety. exclusion criteria: * not being able to understand the nature of the study and / or the procedures to be followed * not signing the informed consent * be under the age of 18 * pregnancy * being diagnosed with anxiety disorder or being treated with anxiolytics * patients suffering from vertigo * patients with epilepsy * active ear infection * patients with diagnosed hypertension * patients with cardiovascular disease * patients with psychosis or severe mental illness

Keywords: hysteroscopy pain virtual reality anxiety
effects of education program for lebanese diabetic t2 in their behavior of auto managing, of self-efficacy and adhesion

Conditions: Diabetes Mellitus

Summary: diabetes mellitus is a disease of great frequency and is a major public health problem. in lebanon, the incidence of diabetes is estimated at 12%, it is expected to double by the year 2025. given the increasing prevalence of diabetes in lebanon, the evolution of complications of this disease and the lack of studies at this level, it is appropriate to conduct a study that aims to evaluate the effects an education program for people with type 2 diabetes on their sense of self-efficacy and their ability to self-manage their disease to make them the most optimal therapeutic adherence possible. the design of this study is experimental type before / after randomization by diabetic patients. education program delivered to the experimental group is the "accu-chek education program" of roche. membership will be assessed using a biomarker hba1c should be \<7%, and a questionnaire (summary of diabetes self-care activities measure), which measures self-care behaviors. self-efficacy is measured using the diabetes management self-efficacy scale. and this before the intervention and 3 months later. the sample will be 240 diabetic patients t2. recruitment will be in outpatient diabetology a hospital located in beirut. statistical analyzes used for descriptive variables are measures of central tendency, dispersion and frequency distribution. t-test and chi-square will be used to compare the socio-demographic characteristics of the 2 groups, experimental and control. to test hypotheses and determine the difference in the results of the dependent variables of the 2 groups, analysis of variance and covariance are used. the data will be processed using spss version 14.0.

1. following the implementation of a program of education, feeling of self-efficacy participants will be higher in the experimental group than in the control group. 2. following the implementation of a program of education, self-management behaviors: monitoring the diet, the practice of physical exercise, self-monitoring blood sugar, taking medications and care feet, participants will be higher in the experimental group than in the control group. 3. following the implementation of a program of education, the percentage of participants who have an hba1c less than 7 will be higher in the experimental group than in the control group.

Eligibility criteria:
inclusion criteria: * 18 years and over, * suffering from type 2 diabetes for at least one year, * lebanese speak, read and write arabic, * have an hba1c ≥ 7% exclusion criteria: * mental impairment * a psychological problem uncontrolled and medicated

Keywords: diabetic type2 education self-management behaviors self-efficacy hba1c
evaluating monitoring techniques for postoperative spinal cord ischemia

Conditions: Monitoring; Postoperative; Spinal Cord Ischemia; Thoracoabdominal Aneurysm; TAAA; NIRS; Long Loop Reflexes; F-waves

Summary: during open surgery of a thoraco-abdominal aortic aneurysma (taaa), diminished blood flow to the myelum can result in hypoxia, compromising proper function of the spinal cord. intraoperatively, motor evoked potentials (mep) are elicited to measure the functional integrity of the spinal cord. meps have proven to be a reliable marker of spinal cord ischemia. moreover, these potentials react within minutes, which facilitates interventions to restore the blood flow. monitoring intraoperatively with this ancillary test has reduced the rate of paraparesis to \< 5%. unfortunately, in the early postoperative period, spinal cord vulnerability is high. therefore, some patients develop paraparesis, not during the surgical procedure, but after the surgical procedure. postoperatively, suboptimal blood flow may lead to critical loss of function. this inadequate perfusion results in "delayed paraparesis". in the postoperative patient, it is not possible to measure meps when sedation is decreased, due to the high intensity of the electrical stimulus, which is unacceptably painful in the unanesthetized or partially anesthetized patient. therefore ancillary tests are needed which can detect spinal cord ischemia postoperatively early, thus preceding the phase with clinically overt paraparesis. the test should be reliable and easy to perform for an extended period of time (up to several days). the purpose of this study is to explore the usefulness of various neurophysiological tests regarding accuracy and feasibility for the detection of spinal cord ischemia. in particular, to find a diagnostic test which is acceptable for the unanesthetized or partially anesthetized patient and therefore can also be performed postoperatively. these tests will be examined in fully sedated as well as partially sedated patients. the following candidate tests will be examined: 1. long loop reflexes (llr) consisting of f-waves. 2. oxygenation measurements of the paraspinal muscles using near-infrared spectroscopy (nirs).


Eligibility criteria:
inclusion criteria: * thoraco-abdominal aneurysm (taa) of the descending aorta: crawford type i,ii, iii, iv or v * repair using open surgical or endovascular procedure. * undergoing monitoring by motor evoked potentials (mep) as part of the standard surgical procedure. exclusion criteria: * aneurysm only in ascending part of the aorta * standard contraindications for motor evoked potential (mep) monitoring. * standard contraindications for electrode placement (skin wounds, etc.) * no informed consent can be obtained prior to the procedure

Keywords: spinal cord ischemia postoperative thoracoabdominal aneurysm monitoring
antibody and delayed cyclosporine versus initial cyclosporine alone in patients receiving kidney transplants

Conditions: Kidney Transplantation; Chronic Allograft Nephropathy

Summary: the purpose of this study is to see if kidney function can be improved during transplants by giving the drug thymoglobulin with delayed cyclosporine treatment instead of initial cyclosporine treatment. there have been improvements for patients receiving kidney transplants, yet acute rejection is still a problem. this can lead to kidney failure over time. patients whose graft fails to function properly in the first week after transplant do not do as well after 5 years as compared to patients without early problems. this study will see if thymoglobulin, a drug that suppresses the immune system, will improve early graft function.

while graft survival of post renal transplant has improved over the last decades, acute rejection remains a problem that clinical research has sought to minimize through improved strategies. graft survival prognosis is significantly worsened in patients whose allografts exhibit delayed function and patients may require early dialysis. data shows that cadaveric organ recipients requiring dialysis use in the first transplant week have a 5-year post-graft survival rate of 51 percent compared to 70 percent for those free of this complication. a recent evaluation of thymoglobulin (a rabbit-derived polyclonal antibody; an immunosuppressant) suggests it is an effective agent worthy of further evaluation as induction therapy. this trial evaluates whether a decreased dgf is seen with an improved day 90 graft function. recipients of a first or second cadaver kidney transplant are randomized pre-transplant to 1 of 2 treatment groups. one group receives antibody therapy (thymoglobulin) at the time of transplant and delayed cyclosporine therapy. the other group starts cyclosporine therapy at the time of transplant without thymoglobulin. dgf is diagnosed by a less than 20 percent decrease in the serum creatinine levels in the first 24 hours post-transplant and/or the need for dialysis. patients on the antibody arm receive additional antibody if they experience dgf. biopsies are performed in all cases of suspected rejection and any patient with biopsy-confirmed acute cellular rejection receives treatment. patients have regular examinations including blood tests and are evaluated for kidney function and incidence of complications for 24 months after the transplant. the trial endpoint of graft function encompasses graft survival and graft function as calculated by creatinine clearance.

Eligibility criteria:
inclusion criteria patients may be eligible for this study if they: * are receiving a first or second kidney transplant. * are at least 21 years old. * understand the purposes and risks of the study and have given consent. * agree to use an acceptable form of birth control for a year following transplant. exclusion criteria patients will not be eligible for this study if they: * have received a kidney transplant from a living donor. * have had multiple organ transplants. * are allergic to thymoglobulin (contains a rabbit protein). * are pregnant.
a study of herceptin (trastuzumab) in combination with 2nd-line chemotherapy in patients with her2 positive metastatic breast cancer.

Conditions: Breast Cancer

Summary: this 2 arm study will compare the efficacy and safety of continuation or discontinuation of herceptin treatment in combination with 2nd line chemotherapy, in patients with her2 positive metastatic breast cancer whose condition has progressed on 1st line chemotherapy plus herceptin. patients will be randomized either to continue or discontinue herceptin treatment (6mg/kg iv infusion every 3 weeks) while receiving second-line chemotherapy of the investigator's choice. the anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.


Eligibility criteria:
inclusion criteria: * female patients, \>= 18 years of age; * metastatic breast cancer; * her2 overexpression (ihc 3+ and/or fish positive); * disease progression during or after previous 1st line chemotherapy + herceptin; * scheduled to receive 2nd line chemotherapy. exclusion criteria: * concurrent immunotherapy or hormonal therapy; * anthracyclines as part of previous 1st line chemotherapy or planned 2nd line chemotherapy; * cardiac toxicity during previous 1st line chemotherapy + herceptin; * history of other malignancy within last 5 years.
hunter outcome survey (hos)

Conditions: Hunter Syndrome

Summary: the purpose of this study is to collect data that will increase understanding of hunter syndrome. the data from hos may provide guidance to healthcare professionals about disease treatment options.


Eligibility criteria:
inclusion criteria: 1. diagnosis of hunter syndrome (biochemically and/or genetically) 2. signed and dated written informed consent, as per either a or b below: 1. prospective participants: signed and dated written informed consent from the participant or, for participants aged less than (\<) 18 years (\<16 years in scotland), parent and/or participant's legally authorized representative (lar), and assent of the minor where applicable. informed consent must be obtained from lars for cognitively impaired participants, where applicable. or 2. historical participants: signed and dated informed consent from the participant's lar (where allowed by relevant individual country or site regulations/laws). . exclusion criteria: 1. participants enrolled in an interventional clinical trial are not eligible. participants may re-enroll once they have completed or withdrawn from the other clinical study. 2. participants receiving treatment for hunter syndrome with an ert product other than elaprase are not eligible. participants may enroll or re-enroll once they have stopped treatment with another ert.

Keywords: mucopolysaccharidosis ii hunter syndrome enzyme replacement therapy lysosomal glycosaminoglycans
to evaluate the safety and efficacy of intracranial stent assisted endovascular treatment of intracranial aneurysms

Conditions: Intracranial Aneurysm

Summary: the purpose of this study is to assess safety and effectiveness of the pegasus stent system.

title: a prospective, multicenter, single-arm clinical trial to evaluate the safety and efficacy of pegasus stent system for assisted endovascular treatment of intracranial aneurysms device: pegasus stent system design: prospective, multicenter, single arm clinical study. purpose: to assess safety and effectiveness of the pegasus stent system. study duration: 31 months. sample size: 130 patients. number of sites: ≤10. follow-up time: 12 months.

Eligibility criteria:
inclusion criteria: * aged from 18 to 80 years, male or female; * patients diagnosed as wide-neck intracranial aneurysms by brain cta/mra/dsa (neck width≥4mm or bodyor a dome-to-neck ratio\<2); * parent vessel with a diameter of ≥2.5mm and ≤4.5mm; * patients target aneurysm is planned to be embolized using intracranial stent assisted with coiling; * the mrs score of the patients was 0-2; * patients understand the purpose of the study, accept the follow-up period, and agree to comply with all requirements, agree to participate in the clinical trial and voluntarily sign the informed consent. exclusion criteria: * patients who have contraindications to antiplatelet and/or anticoagulant therapy or do not start antiplatelet therapy in time before treatment. * patients with anatomical structure is not suitable for endovascular treatment due to severe vascular tortuosity or stenosis shown by angiography. * known to be allergic to nitinol platinum alloy and angiographic agents. * conditions that in the opinion of the investigators would prevent patients from completing the study, such as the expected survival period of active tumor less than 1-year, high-risk group of cerebral thrombosis, heart failure and atrial fibrillation. * patients combined moyamoya disease, intracranial tumor, intracranial arteriovenous malformation, intracranial arteriovenous fistula and intracranial hematoma. * the target aneurysm has previously received intravascular embolization or stent implantation treatment; * multiple aneurysms or complex aneurysms; * patients with acute ruptured aneurysm; * serious infection is not controlled and is not suitable for operation; * patients who underwent major surgery or interventional therapy (such as brain, cardiac, chest, abdominal or peripheral vascular) within 30 days before surgery; * obvious abnormal coagulation function or bleeding tendency; * combined with severe renal insufficiency, creatinine greater than or equal to 200umol/l; patients with severe liver diseases (such as acute and chronic hepatitis, cirrhosis), or alt more than 3 times the upper normal limit; * pregnancy, lactation, or women of childbearing age who plan to be pregnant during the study period; * participation in any other clinical trial within 30 days prior to signing informed consent; * other conditions considered by the investigator to be inappropriate for enrollment.
interleukin23 in systemic lupus

Conditions: Systemic Lupus Erythematosus Related Interstial Lung Disease

Summary: assement of interleukin 23 in serum of patients with systemic lupus erythematosus related interstial lung disease .

for all patients detailed history taken clinical and rhumatological examination will be assessed and sledai score will be collected from the case record of the patients\&laboratory investigation included 1_erythrocytic sedimentation rate.2_complete blood count.3_interleukin23 .4_complement 3\&4.5_antinuclear antibodies.6_anti double stranded antibodies.7_full basic biochemical test(24 urine protien)8_high resolution computed tomography.

Eligibility criteria:
inclusion criteria: * patients with systemic lupus erythematous and patients with systemic lupus erythematosus with interstial lung disease. exclusion criteria: * patients with chest conditions rather than interstial lung disease \&who receiving biological blocking antibodies\& those treated with immunosuppressive drugs.
efficacy of mobilization with movement on conditioned pain modulation in chronic low back pain patients

Conditions: Chronic Low-back Pain

Summary: patients with chronic low back pain may have altered endogenous mechanisms, which can be evaluated with conditioned modulation paradigms. mobilization with movement has demonstrated improvements in endogenous analgesic mechanisms in conditions such as knee osteoarthritis or lateral epicondylalgia. however, its effects have not yet been studied in patients with chronic low back pain. the objective of this randomized clinical trial is to evaluate the efficacy of mobilization with movement compared to placebo on endogenous mechanisms in patients with chronic low back pain.

low back pain is the leading cause of disability worldwide, and chronic low back pain (clbp) has a prevalence of 2-25%, 80% of which are classified as non-specific low back pain because the causal factors have not yet been determined. although different mechanisms can be attributed to the chronification of pain, a frequent denominator is the amplification of nociceptive transmission or decreased inhibition of nociceptive stimuli in the peripheral and/or central nervous system. to assess inhibitory pathways, conditioned pain modulation (cpm) paradigms are commonly used in humans. they are based on the idea that a noxious stimulus applied to one part of the body can inhibit pain elsewhere by activating the descending inhibitory system. when cpm is evaluated in patients with chronic low back pain, contradictory results are found, with studies reporting an alteration of pain modulation mechanisms and others not. different studies found that manual therapy can improve cpm compared to sham in patients with chronic musculoskeletal pain, such as lateral epicondylalgia or knee osteoarthritis. however, its effects in patients with chronic low back pain have not yet been studied. therefore, the aim of this study was to investigate the effect of mobilization with motion on cpm in patients with chronic musculoskeletal pain.

Eligibility criteria:
inclusion criteria: * adults with chronic low back pain (\>3 months of pain duration) * 2 or more on a scale of 0 to 10. exclusion criteria: * radiculopathy * neurological signs, symptoms, or deficit * rheumatic or autoimmune disease * cutaneous disease * history of fracture or spinal surgery * pregnancy * neuropathic pain * active cancer * spondylolysis/spondylolisthesis * mild/severe cognitive impairment which interferes with outcomes measurement

Keywords: chronic low back pain manual therapy conditioned pain modulation